Determination of Regulatory Review Period for Purposes of Patent Extension; GORE CARDIOFORM ASD OCCLUDER, 34023-34025 [2021-13687]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, TAZVERIK
(tazemetostat). TAZVERIK is indicated
for the treatment of adults and pediatric
patients aged 16 years and older with
metastatic or locally advanced
epithelioid sarcoma not eligible for
complete resection. This indication is
approved under accelerated approval
based on overall response rate and
duration of response. Continued
approval for this indication may be
contingent upon verification and
description of clinical benefit in
confirmatory trials. Subsequent to this
approval, the USPTO received a patent
term restoration application for
TAZVERIK (U.S. Patent No. 8,410,088)
from Epizyme, Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
March 1, 2021, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of TAZVERIK
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
VerDate Sep<11>2014
17:39 Jun 25, 2021
Jkt 253001
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
TAZVERIK is 1,618 days. Of this time,
1,372 days occurred during the testing
phase of the regulatory review period,
while 246 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: August 21,
2015. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on August 21, 2015.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: May 23, 2019. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
TAZVERIK (NDA 211723) was initially
submitted on May 23, 2019.
3. The date the application was
approved: January 23, 2020. FDA has
verified the applicant’s claim that NDA
211723 was approved on January 23,
2020.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 650 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
34023
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13743 Filed 6–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–5831]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GORE CARDIOFORM ASD
OCCLUDER
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined the regulatory review period
for GORE CARDIOFORM ASD
OCCLUDER and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 27, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 27, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 27,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 27, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
E:\FR\FM\28JNN1.SGM
28JNN1
34024
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–E–5831 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; GORE
CARDIOFORM ASD OCCLUDER.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
VerDate Sep<11>2014
17:39 Jun 25, 2021
Jkt 253001
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device, GORE CARDIOFORM
ASD OCCLUDER. GORE CARDIOFORM
ASD OCCLUDER is indicated for the
percutaneous, transcatheter closure of
the following defects of the atrial
septum: Ostium secundum atrial septal
defects (ASDs), patent foramen ovale to
reduce the risk of recurrent ischemic
stroke in patients, predominantly
between the ages of 18 and 60 years,
who have had a cryptogenic stroke due
to a presumed paradoxical embolism, as
determined by a neurologist and
cardiologist following an evaluation to
exclude known causes of ischemic
stroke. Subsequent to this approval, the
USPTO received a patent term
restoration application for GORE
CARDIOFORM ASD OCCLUDER (U.S.
Patent No. 9,474,517) from W.L. Gore &
Associates, Inc., and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
January 21, 2020, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of GORE
CARDIOFORM ASD OCCLUDER
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
GORE CARDIOFORM ASD OCCLUDER
is 931 days. Of this time, 751 days
occurred during the testing phase of the
regulatory review period, while 180
E:\FR\FM\28JNN1.SGM
28JNN1
34025
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Notices
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: November 10, 2016. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) for human tests to
begin, as required under section 520(g)
of the FD&C Act, became effective
November 10, 2016.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): November 30,
2018. FDA has verified the applicant’s
claim that the premarket approval
application (PMA) for GORE
CARDIOFORM ASD OCCLUDER (PMA
050006 S071) was initially submitted
November 30, 2018.
3. The date the application was
approved: May 28, 2019. FDA has
verified the applicant’s claim that PMA
050006 S071 was approved on May 28,
2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 556 days of patent
term extension.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13687 Filed 6–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0281]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 27, 2021.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0281–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, or call (202)
795–7714 the Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
SUMMARY:
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Prevention
Communication Formative Research.
Type of Collection: Revision.
OMB No.: 0990–0281.
Abstract: The Office of Disease
Prevention and Health Promotion
(ODPHP) is focused on developing and
disseminating health information to the
public. ODPHP faces an increasingly
urgent interest in finding effective ways
to communicate health information to
America’s diverse population. ODPHP
strives to be responsive to the needs of
America’s diverse audiences while
simultaneously serving all Americans
across a range of channels, from print to
new communication technologies. To
carry out prevention information efforts,
ODPHP is committed to conducting
formative and usability research to
provide guidance on the development
and implementation of their
communication and education efforts.
The information collected will be used
to improve communication, products,
and services that support key office
activities including: Healthy People,
Dietary Guidelines for Americans,
Physical Activity Guidelines for
Americans, the Move Your Way
Campaign and the President’s Council
on Sports, Fitness & Nutrition. ODPHP
communicates through its website
(www.health.gov) and through other
channels including social media, print
materials, interactive training modules,
and reports. Data collection will be
qualitative and quantitative and may
include in-depth interviews, focus
groups, web-based surveys, omnibus
surveys, card sorting, and various forms
of usability testing of materials and
interactive tools to assess the public’s
understanding of disease prevention
and health promotion content,
responses to prototype materials, and
barriers to effective use.
The program is requesting a 3-year
extension of the clearance.
ANNUALIZED BURDEN HOUR TABLE
Forms
(if necessary)
Number of
respondents
In-depth interviews—Screener ........................................................................
In-depth interviews—Instrument ......................................................................
Focus groups—Screener .................................................................................
VerDate Sep<11>2014
17:39 Jun 25, 2021
Jkt 253001
PO 00000
Frm 00059
Fmt 4703
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Number of
responses per
respondents
1,500
500
2,925
E:\FR\FM\28JNN1.SGM
1
1
1
28JNN1
Average
burden per
response
10/60
1.00
10/60
Total burden
hours
250
500
487.5
]]>Agencies
[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Notices]
[Pages 34023-34025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13687]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-E-5831]
Determination of Regulatory Review Period for Purposes of Patent
Extension; GORE CARDIOFORM ASD OCCLUDER
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined the regulatory review period for GORE CARDIOFORM ASD
OCCLUDER and is publishing this notice of that determination as
required by law. FDA has made the determination because of the
submission of an application to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that medical device.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 27, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by December 27, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 27, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 27, 2021. Comments
received by mail/hand delivery/courier (for written/paper
[[Page 34024]]
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-E-5831 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; GORE CARDIOFORM ASD OCCLUDER.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device, GORE CARDIOFORM
ASD OCCLUDER. GORE CARDIOFORM ASD OCCLUDER is indicated for the
percutaneous, transcatheter closure of the following defects of the
atrial septum: Ostium secundum atrial septal defects (ASDs), patent
foramen ovale to reduce the risk of recurrent ischemic stroke in
patients, predominantly between the ages of 18 and 60 years, who have
had a cryptogenic stroke due to a presumed paradoxical embolism, as
determined by a neurologist and cardiologist following an evaluation to
exclude known causes of ischemic stroke. Subsequent to this approval,
the USPTO received a patent term restoration application for GORE
CARDIOFORM ASD OCCLUDER (U.S. Patent No. 9,474,517) from W.L. Gore &
Associates, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated January 21, 2020, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of GORE CARDIOFORM ASD OCCLUDER represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
GORE CARDIOFORM ASD OCCLUDER is 931 days. Of this time, 751 days
occurred during the testing phase of the regulatory review period,
while 180
[[Page 34025]]
days occurred during the approval phase. These periods of time were
derived from the following dates:
1. The date an exemption for this device, under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360j(g)), became effective: November 10, 2016. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) for human tests to begin, as required under section 520(g) of the
FD&C Act, became effective November 10, 2016.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): November
30, 2018. FDA has verified the applicant's claim that the premarket
approval application (PMA) for GORE CARDIOFORM ASD OCCLUDER (PMA 050006
S071) was initially submitted November 30, 2018.
3. The date the application was approved: May 28, 2019. FDA has
verified the applicant's claim that PMA 050006 S071 was approved on May
28, 2019.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 556 days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13687 Filed 6-25-21; 8:45 am]
BILLING CODE 4164-01-P
